A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.

An Open Multicentre Phase III Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Severe Haemophilia A.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02246894

Enrollment

Unknown

Registered

2014-09-23

Start date

2003-11-30

Completion date

Unknown

Last updated

2018-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilia A

Brief summary

The main objectives of this study are: * to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed). * to assess clinical outcome when treating a bleed with Optivate®. * to evaluate Optivate® in terms of clinical tolerance and safety in children under the age of 6 years. . * to assess FVIII inhibitor development during the study.

Interventions

BIOLOGICALOptivate® (Human Coagulation Factor VIII)

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Years

Healthy volunteers

Inclusion criteria

* Children under the age of 6 years with a diagnosis of severe Haemophilia A. Subjects who required FVIII therapy and did not demonstrate inhibitors to FVIII. Children with history of inhibitors to FVIII or clinically significant renal or liver disease were not eligible to participate in the study.

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Consumption of FVIII	Day 0 to Week 26

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026